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The aim of the Walk BEST study is to provide evidence that it is feasible to implement the technology assisted gait- focused walking program Walk-BEST™ in older adults with osteoporosis, and that this program is acceptable to this population.
The Walk-BEST™ technology assisted gait optimization program has demonstrated effectiveness in improving gait pattern and walking capacity without adverse events in people living with Parkinson's and Multiple Sclerosis. What is not known and the topic of this pilot and feasibility study is whether older people with osteoporosis will engage successfully with this program, since they do not have a diagnosis of a disabling condition affecting gait and may be unaware that their cautious method of walking exposes them to higher risk of falls and fractures rather than protecting them.
A randomized pilot and feasibility study (PAFS) will be conducted with groups randomized in a 1:1 ratio. Participants will be randomly assigned to either 1) immediate receipt of the Walk-BEST™ program; or 2) wait-list control and delayed receipt of Walk-BEST™ program 3 months post-randomization.
Participants will receive a copy of a proprietary workbook with instructions on simple exercises targeting strength, flexibility, and balance to facilitate a better walking pattern, as well as both 3-5 remote sessions with an exercise professional to practice walking well and to learn how to use the Heel2ToeTM sensor, and two technology phone calls with a research team member, over the first 4 weeks of the intervention. This personal gait training period will be followed by independent home practice over 2 months, during which participants will be instructed to practice walking with the sensor for a minimum period of 6 min, twice a day and to complete three exercises from their workbook at least twice a week.
There will be three on-site study visits at 3-month intervals: one for initial assessment, and two for reassessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Walk-BEST Immediate | Experimental | Assigned to receive the Heel2Toe sensor and Walk BEST intervention right away. |
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| Walk-BEST Delayed | Active Comparator | Assigned to receive the Heel2Toe sensor and Walk BEST intervention after a delay of 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device: Heel2Toe[TM] sensor | Device | Heel2Toe is a new generation of wearables that provides real-time auditory feedback when the person takes a good step, one in which the step is initiated with a strong heel strike. |
| Measure | Description | Time Frame |
|---|---|---|
| Study recruitment rates (feasibility objective) | The study will be considered feasible if the investigator can recruit 28 participants | 3 months |
| Study retention rates (feasibility objective) | The study will be considered feasible if ≥ 75 % of the sample completes the final assessment | 9 months |
| Adherence to intervention (feasibility objective) | The intervention will be considered feasible if participants complete ≥ 65% of the prescribed number of walking sessions at the 6-month follow-up. | 9 months |
| Perceived acceptability and usability of the Heel2Toe sensor (feasibility objective) | The acceptability outcomes will be based on an exit debriefing questionnaire. Usability of the Heel2Toe sensor will be quantified with items from the Digital Health Devices Usability Indicators. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional walking capacity | Six Minute Walk Test (6MWT) | Change from Baseline to 3 months, 6 months |
| Grip strength | Hand Dynamometer |
| Measure | Description | Time Frame |
|---|---|---|
| Angular velocity of ankle during three phases of gait cycle, heel-strike, push-off, swing averaged over a walk of at least 50 steps | Degrees per second | Change from Baseline to 3 months, 6 months |
| Co-efficient of variation of angular velocity of ankle during three phases of gait cycle, heel-strike, push-off, swing averaged over a walk of at least 50 steps |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Velizara Garkova, MSc | Contact | 514-934-1934 | 47071 | velizara.garkova@rimuhc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Suzanne Morin, MD | RI-MUHC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute of the McGill University Health Centre | Recruiting | Montreal | Quebec | H4A 3S5 | Canada |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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Waist-List Control
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All participants eventually receive the intervention. The primary outcomes are feasibility outcomes. Gait quality is measured directly from the sensor and is not affected by observers.
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| Technology-assisted therapeutic walking program | Behavioral | Co-designed, evidence-based technology-assisted, therapeutic walking program developed by physiotherapy researchers, clinicians, and frail and non-frail seniors. It consists of training elements (derived through international consensus and endorsed by 600 older Canadians) for optimal gait pattern with the use of a biofeedback device, the Heel2Toe™ sensor, which is introduced to reinforce the gait optimizing training and encourage home practice. |
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| Change from Baseline to 3 months, 6 months |
| Balance | Mini-Best Test (0-28; higher is better) | Change from Baseline to 3 months, 6 months |
| Functional leg muscle strength | 30-second Chair stand test | Change from Baseline to 3 months, 6 months |
| Fear of falling | 6-Item Revised Fear of Falling Questionnaire (6-24, lower is better) | Change from Baseline to 3 months, 6 months |
| Physical activity | Physical Activity Scale for the elderly (0-400+; higher is better) | Change from Baseline to 3 months, 6 months |
| Lower limb function | Lower Extremity Functional Scale (0-80; higher is better) | Change from Baseline to 3 months, 6 months |
| Quality of Life | Older Persons Active Living Related Quality of Life (8-32, higher is better) | Change from Baseline to 3 months, 6 months |
| Falls | Number of falls reported in the falls calendar | Change from Baseline to 3 months, 6 months |
Degrees per second |
| Change from Baseline to 3 months, 6 months |
| D009750 |
| Nutritional and Metabolic Diseases |